Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced two FDA approvals-- sumatriptan succinate injection and rocuronium bromide injection. Sumatriptan succinate injection (sumatriptan) will be available in 6 mg per 0.5 mL latex-free vials. Rocuronium bromide injection will be available in latex-free vials of 50 mg per 5 mL and 100 mg per 10 mL.
According to 2009 IMS data, the US market for injectable sumatriptan approximated$22 million and $59 million for rocuronium.
“The addition of sumatriptan and rocuronium vials further expands our portfolio of injectable products,” said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. “Migraine and cluster headaches are serious medical conditions and sumatriptan is a frequently prescribed medication for the treatment of these afflictions while rocuronium use is vital in many critical surgeries. Sumatriptan and rocuronium will include Sagent’s proprietary PreventIV Measures labeling and packaging, which can help clinicians differentiate these offerings from other products or dosages.”
Sumatriptan and rocuronium will be the eighth and ninth products approved under the Sagent and Strides Arcolab partnership. Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the US market. Strides is responsible for developing and supplying injectable products which Sagent markets in the United States.
Sumatriptan for injection is the generic equivalent of GlaxoSmithKline’s Imitrex. Sumatriptan is a vascular headache suppressant indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes. It is not for use in the management of hemiplegic or basilar migraine.
Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an addition to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
PreventIV Measures is Sagent’s comprehensive, user-driven and patient-centered approach to product labeling and packaging that is designed to help prevent medication errors. It incorporates unique label and carton designs, cap and label colors, bar coding and other features that are designed to make it easier to differentiate drugs and identify the correct dose.